TransMedics (TMDX) 3 Mar 212020 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to TransMedics Q4 2020 Earnings Conference. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's call is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Ms. Lewis. Lynn ma'am. ahead, go Please

company's you. Earlier quarter A results the on released of today, full year TransMedics the available and is XXXX. press financials ended the for release Thank website. December copy XX,

contained statements results Before Securities within will in call call Reform forward-looking opportunity expenses statements management you XXXX, Act various operating Safe for make our products, not these pursuant and these growth could and our financial Any organization, include material of to risks and meaning which events Litigation or gross potential approvals provisions I'd federal predictions we without revenue, events, upon and the forward-looking which XXXX. margins, to our during Harbor those statements trends, in assumptions. reliance undue expectations, in you statements, to guidance expectations differ and are involve are operating that from like made begin, include results relate reimbursement, future remind statements. that actual based including commercial or of Accordingly, or should this expectations our to that for statements. regulatory our statements, current of expectations for our that future the are or this examination limitation, materially the implied All cause Private forward-looking anticipated statements. and by securities place on of uncertainties These and forward-looking of laws, the performance estimates

forward-looking statements, filed the our projections report XXXX. sensitive as XX, and quarter the except section on on quarterly refer that, information, for on Officer. third new I'll Commission and business, and disclaims information and Securities to Risk TransMedics our with whether filings, For and Hassanein, This over of other uncertainties of the XXXX, revise Factors intention with description future XX-K, required Exchange a including is associated Waleed please risks any update Report call otherwise. as because XX-Q X, Chief by the XXXX. Annual to events Form Form time our or law, supplemented by only the or SEC our list the to contains of March with as March or And of of today, accurate obligation, President or financial Executive call turn broadcast, live conference Waleed? any

fourth Thank earnings much, TransMedics Good quarter afternoon XXXX welcome so you full everyone call. Lynn. year and to and

Stephen our Financial is today me Gordon, Chief Joining Officer.

a on of the would like cover challenging XXXX in COVID made faced was on we significant topics progress on pandemic, due I of think on strong many year today. four strategic we the Despite most we fronts, several TransMedics the to to major XXXX our initiatives. And upcoming in the key to the one it and very all in the agree our delighted challenges position catalyst that of year to of significant can capitalize call see ended many many XXXX. I us following end. global were

results financial our the the quarter review will for I and year. First, full

Second, key achieved XXXX. I review strategic progress our in the on will initiatives

overview Third, on XXXX. impact and like catalyst potential Fourth and finally, I preview for business. provide I to XXXX will upcoming in our their an would our the of strategy

detailed for this Let and call. will financial of by in XQ FYXXXX, results financial our section Stephen me the his summarizing performance start cover

year-over-year which $X.X net million, Our revenue XX% and outperformed XQ represent was expectations growth.

over For XXXX million, representing XXXX, the revenue. X% our growth was year revenue net $XX.X full

revenue contributing the to by our throughout driven growth was in OCS year. growth attributable primarily business, our overall of approximately our three XX% U.S. to all U.S. Our having platforms

we're we the challenges programs and the as largely OCS a encouraged recovered XXXX. commercial and year well recovery an QX, of early activities QX. that Heart slowing DCD transplant active in in Overall, despite our OCS had Lung throughout our And and quarter as we OCS of the the Specifically, throughout in Lung Liver XXXX, of fourth trajectory. QX business the COVID-related ended year significant procedures on encouraging

growth focused We that upcoming and in that we've our accelerate now catalyst pairing on foundation are leveraging established XXXX, future the beyond. XXXX the in growth and XXXX to with

Let represent the strategic key we and in a provide future to me of that solid turn XXXX achieved the foundation summary second believe initiatives five a topic operational progress for our growth.

National provider the plan launched our and U.S. retrieval we coverage of Lungs U.S., for XXXX, with XXXX. realize adding Program, New our liver organ help In Program. expanding England, started and we We the growing and achieved. designed activities area, XXXX national one the it the OCS to in are started to active into OCS-related Chicago with the to region. National FDA clinical our management the regional transplant active for We Chicago XXXX all the exclusive ended continue is which four OCS heart and OCS approvals region the TransMedics First, expanded vision to in be centers once and U.S. regions We with and across throughout initial Dallas Atlanta,

regional the scalable last established year, expansion also we foundation successfully to National scale Program. help and a to addition OCS the operationalize In

Let few me share a examples.

for for and process potential developed perfusion screening standardizing, we Lung donors management. suitability First, OCS a new for

that platform. goal early process potential screening screen donor involved every have downstream. expertise the transplantation decision-making ecosystem transplantation be active ultimate The utilization established us currently XX/X to and donor enables maximize supported regions hopefully facilitate digital in by to clinical in. to we're is the for We a lung for clinical OCS This using

the done of network adequate supplementing surgical coverage team potential thereby are Second, was on our we while established platform, every to quality care surgical TransMedics, that donor management. lung OCS of This the OCS retrieval capabilities. national and ensure contracted by surgical the expertise standardizing directly a of

Third, also awareness every U.S. on in XXXX, broad within a the we transplant focused educating stakeholder campaign launched community.

entity transplant leadership, or payers, administration, Program OPTN be OPTN. to federal manages commercial going both overall and organ contract a finally, We clinical is the of target both transplantation CMS. organ significant and organ procurement Specifically, transplant the driver procurement programs, in growth going administration we U.S. of the and And is leadership, forward. that administrative National our clinical payers network, U.S. and believe that organization, the the OCS

Liver The the second OCS major initiative PMA. is

reminder, the and As Liver filed back data analysis we PMA our XXXX. completed a QX in

We start the Liver are have QX next since discussions now will the discuss CAP And meeting tranche trial, all the which will the the responses of our with hopefully to currently schedule working with FDA to of to happen initiate PMA, FDA's addressed in and And QX panel which we Building several submitted in I XXXX. momentum PROTECT for Liver in the advisory in OCS the completed months. tranche on FDA the as the OCS shortly, questions. we've hopefully active first OCS Liver clinical CAP, of XXXX. late second Liver will we're of

DCD initiative the OCS Heart patient We DCD was XXXX XXXX. key XXX third advancing OCS Our in indication. trial completed

We are now the post-transplant. of awaiting follow-up the graft effectiveness months for the and completion patient survival period primary six of endpoint

top expect readout QX We this XXXX. line the of important in program

important and this to in transplant we enrollment As FDA CAP drive I mentioned centers is in a Currently, to formally XXXX. U.S. secured program for earlier, third and in approval major clinical ongoing. program, quarter momentum December of in the the XX CAP CAP initiated actively continue DCD this enrolling

pandemic. our important that that awaiting on critical data the suffered We're OCS Heart the pleased is scheduled the to the this and delays was data anxiously Heart the excited Heart CAP COVID and initiative results, and value our initiative PMA. finally system. trial in XXXX. of panel X, has articulate and meeting FDA date in to ability review April is fourth remain clinical confident This of now DBD I'm and the OCS our to completed OCS process the due Our relieved report the

to Importantly, the FDA's ability confident question or to we're address TransMedics extremely in our panelist. any to

OCS the for phenomenal fifth maintain and across and pandemic. products did unprecedented was midst quality TransMedics supply our XXXX throughout the global a COVID in on initiative job build life-sustaining of the supply final the OCS a the to product and and team world. challenges Lastly, pandemic, continuing the due Despite to to key year laser-focus

issues. we focused product our team supporting to passed on system and laser the quality users international quality maintained to quality patients without all testament certifications Importantly, audits is OCS true any help and they're worldwide. and of clinical This regulatory and our major management our a

front Now, let me us this the in five of year. turn to catalysts major XXXX and

strong I Importantly, foreseeable the these over the potential highlight to foundation impact future. There's trajectory long-term. XXXX a catalysts is of the want that growth overall year to for TransMedics have accelerated growth for lay on to trajectory doubt a defining no an our

of commercial scheduled The course. is is on FDA first the expected which OCS Heart the launch meeting, the actively April DBD preparing panel Heart, pending OCS approval now X, XXXX. of We're catalyst for

We're As currently all currently these with DCD centers CAP heart during we're secured. to are active is in the efforts, OCS National program. a active once our experience planning to the XX part National clinical transplant the are regions to of and add in, scalable of FDA OCS the Heart we program, CAP with preparing Program preparation OCS Program our that given the infrastructure OCS approval in leverage their engaged our

positive coverage where expanding call, regional time hope Heart the addition the are this retrievals. FDA next panel and supporting we we're with Heart increase what and in excited accommodate the commercial are be clinical clinical outcome Finally, of a approval. reporting about to uptake our Overall, potential OCS we’ll actively that in OCS we

we're OCS launch We're Liver FDA and The timeline, to late second of us potential OCS is in Liver planning assuming XXXX. the panel commercial catalyst looking meeting. panel Liver for meeting forward in front OCS reasonable the

planning of programs. for involved PROTECT PROTECT the to active Specifically, engaged we're our add transplant OCS are in OCS doing regions, course. also to CAP Program once similar the centers actively to national the Liver We're and what FDA is the hand, in Liver we're heart, approvals with OCS the that

catalyst supplement. FDA Heard of be FDA catalyst to a line data that it XXXX. just National of is our PMA and in at the This The DCD fourth filing cover filed is major and potential supported targeted in Heart and under once regions potential QX will U.S. the are This optimistic the breakthrough secure. third Liver not cover but trial the expanding catalyst approval is The expansion OCS the to was from or clinical the least the we OCS Program for OCS indication OCS lung, and approval the it of this readout designation, indications in XXXX. XX milestone FDA top

initiated is infrastructure U.S. to the Liver Heart drive we Lung and OCS streamlined more to across the the the OCS National and of the of launch OCS strategy Our Program, leverage for efficient

channels. commercial the maximum maintain the flexibility We to have to by the in capitalize platform to plan through to two OCS We and major strategy. adoption enable up us resources continuing ramp of external begun internal of drive this

First, acquisition with center system. the this and would technology directly be the OCS for responsible purchase the the model, in trans and center organ OCS will direct from managing use TransMedics, case, retrievals they donor

channel cost Heart second OCS the were case very be OCS in the process, OCS the entire and globally. impact OCS adoption center utilization process program. potential transplant to data of The journals. This donor process of additional TransMedics the screening of then extremely the standard while the received transplant, clinical of enthusiastic the DCD through catalyst care for will program, center the clinical technology OCS clinical pay critical Liver, enables We're the more care. is technology These the that about would transformation by organs to maintaining even and in quality the and of the charges managed it and DBD maximum donor for will OCS broader XXXX directly. publications organs of national drivers process final in TransMedics of a accept is plus of perfused trial be facilitate TransMedics and recipient The medical potentially as service OCS high the this for fifth to integrated high

carefully its facts new all call, turn the we on Now, of transplant that to clinical in like let near-term. of we're normalizations recover, impact Today, to or activities more will convinced barring to scientific in U.S. which negative transplant today, continue XXXX, the threat remain that the based our cover we and that's We're peak that topic a and a activity we variance me activities and the expect European outbreak specifically transplant transplant on see the the being volumes. course another to COVID the for on aware remain is I variant U.S. would international final in to major new monitoring and this plans U.S.

and Heart the that Given all performance revenue improving lung, of XXXX, could second incrementally FDA, and of We OCS will the i.e., the revenue expect OCS National primary to which be the the OCS about potential trusted XXXX a its liver tranche Liver now OCS in positioned this is progresses. approved and XXXX indications meaningful heart transplant U.S. QX which the to expected our by opportunity uniquely in and transplantation growth and timing potential confident enthusiastic retrievals in year, partner transplant ecosystem capitalize position end Liver the initiating we new indications, TransMedics OCS the year of three driver liver launch TransMedics of major as commercial this as CAP, with all we remain Program heart We're and organ beyond. lung, and critical manage is later in and clinical OCS to in to redefining establishing of U.S. management national the

be catalysts in of financial for with review guidance that. detailed us, results Chief to not will the full about XXXX to driven for Gordon, at turn our uncertainty will and Financial With I front Steven? Given call Officer impact year. the and the the we this our the that, quarter time many Stephen issuing FDA COVID financial

Thank on QX detail financial the additional you, year. now quarter information and provide the other the some and for will Waleed. I results

development Lung, and revenue the from and XX% million revenue U.S. of gross million. net was of of OCS drivers was few as million revenue from XXXX. strong was key in organ $X.X million OCS the a revenue Net recovery the National In ex-U.S. QX Heart, included momentum XX% quarter $X.X fourth fourth by million after increased of pandemic. of to QX the U.S. $X.X added net Program first, quarters OCS the XXXX. consecutive revenue breakdown U.S. fourth was A on was gross was $X.X the was quarter follows; of OCS sales by and million revenue $X.X million. that of million and $X.X Heart. of For COVID Liver XXXX, revenue net $X.X million million, and up was revenue Lung $X.X OCS Lung, U.S., $X.X the very and increased were, XXXX The quarter from The impacted XX% net was performance revenue were OCS two OCS that's of negatively of recovery. X.X this our

first CAP. Secondly, phase completed U.S. of a in quarter we had Liver OCS the OCS we PROTECT strong sales as the

see fourth $X.X in fourth as operating quarter our commercial margin was impact favorable stocking had of Heart fourth fourth expenses this With $X.X the pandemic. of XXXX. to Also improvements fourth well. U.S., of our of of for a million the liver XXXX. loss sequential continued due $X.X $XX.X compared of saw with orders our in the QX $X.X in use to was did XXXX. revenue at for expectations fourth the Lung of quarter million XXXX, we in lung that Heart offset the Total to the We outside Taiwan, QX quarter XXXX, million XXXX. below reduction and we of result increase we was in OCS Operating operating primarily as invest quarter lower XX% quarter have COVID clinical revenue. XXXX which the net Program from spending of XXXX our sequential of the This which and million in to National quarter line related was compared a the initiated OCS the to limitations was Gross OCS a level were in initiative. million, million, the in loss $X.X quarter And expenses in for the XX% the in

of XXXX. average a securities as XXXX, XX, were shares at which marketable balance the for and December to weighted of XX.X of million from quarter the reduction $XXX.X end the were equates the And equivalents cash QX $X.X million Finally million. outstanding common

share some year fiscal me the let Now XXXX full on details results.

as revenue million heart, net for the grew and was full revenue annual million U.S. By million, net million, which fiscal for XXXX. X% liver. $XX.X for revenue year the down XX% was $X.X The broke $X.X annual was U.S. revenue $X.X $XX.X Outside XXXX XXXX. and prior lung, the $X.X million revenue net by the was detail U.S. for from year. is was for annual – For over million as down over organ, a increase XX% follows; the

in for million XXXX, in net Of loss Operating extremely loss was the in transplant essentially confident due to year the XXXX. the million are million XXXX, COVID total million activity, ability the an here to caused havoc of was year for in $XX we XX% timeline, full was XXXX extremely both in and from forward. the while to it million course to to which $XX.X full we're our $XX.X progress in pandemic was compared $XX.X margin and proud for Overall, managed XXXX, $XX.X to as and expenses the $XX.X in were as well the manner business XXXX, primarily million compared flat and year regulatory compared XX% XXXX the full challenging XXXX. operating our in be year we

prospects are we result meaningful growth upcoming ahead, optimistic the Looking for FDA our revenue as approvals. about of a

We business, reinstating Waleed XXXX that so we're development. COVID formal this mentioned on these our at not critical high infrastructure, to investments. OCS mass of as providing year exists to National guidance is are FDA our commercial do a will progress believe critical we well the our further on a we timelines. defer however generation And XXXX or XXXX in going is I uncertainty spending share, COVID there strategy, increase we and to OCS believe the level next and hold uncertainty time. of in to platform will some accelerate as as environment, Program, We continue to still therefore, mitigated. as back guidance well impact not expect financial on that current achieve that as our For level throughout

the Waleed back for closing to comments. to Now, call I’d like turn

a Stephen. to months team initiatives. leverage on that this OCS you, XXXX, Program made the foundation years, head build the platform in Thank position TransMedics be the coming of for organ challenges that years is our to shape, the positioned Despite upcoming transformative scalable and executing weeks outlined for National end, and uniquely months foundation TransMedics. in I and of well extremely and OCS the the panel year transplanted many in short and OCS will strong few humbly believe success. us. excited operator and majority related the Heart all on a OCS for ahead stakeholders five transplant and in for short vast our we the of scheduled that, Liver the strategic a We've to now, timelines for from we that Heart clinical we're significant focused be catalysts progress national DCD become unprecedented for the across partner With XXXX turn Q&A. the long-term To many to call earlier, we're taking regulatory to now U.S. on to managed am preserved the and will Operator? technology platform. With I truly

question first your from Morgan from Lewis David comes And Stanley.

and environment. and quarter for the taking afternoon, thanks a in a Good challenging nice question

really could year. the to mirror just comment appreciate that improving you and with a maybe tough performance So few me, about get Stephen, or we're tell the guidance. at going least us just I across to you hope But I not environment, for start business

that in six that sequentially sequentially consensus maybe is on level to of be set where could flat couple of the for leaves sort of quarter, better want just more can begin is quarter to of safe If first Hello? quarter? things sort it just And revenues the the to the line the first revenue you, confirm what quarters. range, of assume sort with sort is in us or across got – get which first follow-ups. I I us should to you seven a benchmark

Operator?

Hello.

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Hi technical difficulty. everyone, some apologize, had I we

are So David, call? on you still the

Can here. you I'm me? Sure. hear

can. I

I Great. Did you hear repeat my Should question? question? my

QX have after would I heard your to that. a going growth QX we be is to to the choppy. potential I What flattish from said growth. question little expect about that QX the and is starting bit sequential see

Okay.

the main reason to the tranche, of that CAP kind tranche the a the is from kind to second we'll of out gap Yes, transition first this QX. see Liver in

that. was questions with sequentially work very couple first can And guess solid. lung We the that question I just here, helpful. Waleed, would the of Very the be performance a just Okay. other

some You second predict you through my then just sort which penal the heart but question ask you walk FDA panel, conference, of data the sound well, if the of submitted the what's And just of is here dialogue any dynamics about commercial there? submission of outcome process? Thanks as kind I'll so underpinning with much. us during just incrementally the more can't to been help there's understand And which and confident CAP that agency panel you've the confidence? the with

Thank David. Sure. you,

So question to the the related recovery. lung first

it's good to recovery we're obviously solid think hard recovery further. a in accelerate QX, even I working even that –

end the we see of actually think things the QX. to to demand recovery volume the the and at lung there. contributed that One, were was the year pent-up transplant I hoping back that came three in

the certainly that will that numerous hope meeting lung the never momentum, least awareness, I've to open momentum to need XXXX Relating is. the very said we one continue to to doing and the and the territories predict So the what team active comments our as data on here we FDA transplant, getting the comments availability coming what to will about course, decisions OCS we position. with meet very the original our FDA National our support confidence our confidence be successful can hopefully continue to process what We a this for that that whether no ability, the of awareness and confidence we our comments, can been three, My will we That's we where those FDA one. be lung continue the or us And center, new Program in and results. up feel or that's what panel in that and that's the from, FDA raises on number their that have of arms QX. predict with us and has I having time, to their questions or that focused Number that ability but never have panel, momentum that primarily institutions get to regions outcome began solid the is that to by data two, our four that where forward the the doing outcome expand resonated a gives panel in seeing be would we these business. and resonating mission. our better and are we're in carry hopeful now of and was Heart around not in is, confident hopefully campaign the some of are OCS generated build the our in at feel of questions important confidence but meeting,

months, so Okay, for soon commercial with just, us we’re out just very approval, not in Is last the for And month, if help the we three queue maybe me. a are how jump much. timing heart, one back And once launch? approved I'll then Thanks full helpful. predicting consider that? after you can of approved, is that one just

asking thank it. for an David, and question, That's important you Sure.

the of realistically be to a but we speaking, not it's it than to think a I going be lung. streamlined flip significantly more expect switch,

to the as we somewhere one to campaign to XX took the help Program the to between team but his uplift the in effort doing XX that be preparing importantly, that that have that, are that educational well So And commercialization is days. attribute and launch more streamline the to days the lung ongoing, Tamer going process. for any the and been heart us in National expect to in XX anywhere days lung, to we between see days XXX

starting these, So revenue. much that, our going it's to meaningful based be approval on in from across seeing that we feel impact more us to streamlined some a

Nice Great. quarter. Thanks so much.

you, David. Thank

comes next from from your question And Morgan. Robbie JP Marcus

you to questions. lung apply for Waleed clinical taking had could then a the to you Great. and heart commercial you setting. the launch hoping learnings us to of and minute a the the And some better and just Thanks through what transition increase have from metrics walk utilization from could what there the you system like you through, the managed is before on in, us if walk point and the program could early you versus if any second, you if any to looks in statistics spend liver data account selling OCS where put just you'll a volumes?

Sure. Robbie. Thank you,

XX negatively the first lung between stating the FDA length think I conducting early without trial the was on the lung you’ve pivotal I hiatus the impact commercialization So patient keep before, ground them question, because cycle and the any it stated resulted in the that finishing to but and benefits in think before, the from the review to was clinical a XX public going, the continued is – our access approval. and protocol the technology learnings months from in first as I last the think of biggest learning took months that really it the and momentum that’s starting awareness zero, getting to learning of cloud huge

number we that's our So throughout one. program, heart deliver so the and that's avoided something

the helpful? same given leverage. I scale? that think Second the engagement we the within developed the institutions both in that discussion, on that that be the that be to position, going to programs be liver. we relationship, the with centers, from could our is spent ongoing National are we foundation commercialization, could Program, and truly participation the resources, active integration given on FDA we're given huge heart training, And is engaged our and then and potentially gives for huge transformative is finally, frankly going one how that we with a for scratch for active for planning after lung us really game-changer started they administration, active discussion business Again, How resources here planning approval, our

far what and or saw we're until seeing, certainly year significant But metric to to carefully, want monitoring – next to We comfortably little the – couple publicly. data the part we three going the or heart We able adding we the that within two We is share we Robbie, excited metric goal our data to on the we're more and to very hope question, we're and As under a growth. as more awareness that that I try growth. we're try monitoring it are bit second quarters to to about extrapolate subsequently and wait or have by my every a the carefully board to liver, be revenue from early more question we're and the think need this Program. that coming be percentage saw the versus the but is a belt highlighting to that too point about acquisition from of the earnings that. of direct and to key points our a so point model call we're now National going I

the spending? qualitatively we're revenue mentioned maybe XXXX. but then one increased increased in or spending guidance, one, steer you not can And getting just help you last us in Right. direction quantitatively of Stephen, I realized

Sure. Robbie. Yes,

there. think I look that to and of at which QX We're kind going XXXX get sequentially I think we're quarter. to a million were going spending $XX level close from base, that grow to as I would back to we in

up would be National going base. use as to a this Program. that I ramping aggressively So We're

year. or in going get some you're in quarter the there to at first And point

I in think pretty quarter. first get we'll the close

taking great. the questions. Thanks Okay, for

Robbie. you, Thank

& from Suraj Company. [Operator Instructions] Oppenheimer Kalia next And the is question from

hear Waleed right? afternoon, Good me you Stephen, and all can

hear just Suraj. fine. you Hi, can We

quarter. the on congrats gentlemen, So

OCS panel, Heart you in guys to be gives discussions there level Is make you the obviously, perspective? recommendations is risk so seem going FDA So a a the anything and in with same set reward, Waleed, of of the the that to labeling far the from comfort confident. pretty regarding panel the

discussed We discussions to Suraj, you related for any thank question. labeling. the never the

cart the the putting be horse. we'll think before I

do Our focus right to leadership positive We strong, thing is FDA on to get trust the full. the the labeling. a

the in and streamline think far to will hopefully in foundation through the key to hopefully up so the However, related hand I discuss issues I I the positive at see a process all end there. outcome. is any don't from believe controversial topic go labeling, panel, be,

case, terms of the constraints staff of some transplant approach to least I OCS that agree the – at math and per but of centers for the y'all trying that enough. fact, see program Program, centers, pull in on a basis? offset in have, revenues logistical helping on normalized Waleed, can trying. the of such are see Waleed, through because Fair alleviate does basis? with work costs National the the are are What that You how can y'all a a all normalized are how you some you the incremental

that. say at is is, ability National I've mechanism a to numerous point, we revenue the the the scale, thing the have do adoption Suraj I at And but the disposable this nothing Program we think to the streamline revenue. main as can only of of the times, said, stream OCS primarily process with

again, fronts. infrastructure here win-win on a continue be for we my in is we program And think to it's maturing for the beyond. hope significant It's vision the balance skis fashion. many in cost far to early I life-work So cost, cost, to throughout a involved. and we – don't that it's transplant to And benefit huge time this, again, too able on from logistical it's a believe is that it's cost, prove to be it's forward definitely, but And innings, cost. want XXXX approach there's exactly but significant everybody

Waleed, Heart And questions. this. on a CAP, XX taking when Thank question, my all final for enough. you Fair for give I you that The enrolled? CAP, think y'all me timeline could DCD be missed if patients did forgive

you, Thank Suraj. you. Thank

year-end. speaking, realistically patient CAP, see we up XX much wrapping by pretty think the I

However in patient in the our with keen think discussions publicity the FDA success the FDA U.S. of the and internationally, and the broad and aware the is positive I of very program impact. Heart OCS DCD given about

the I'm not to approval that by So we in hand with hopeful is CAP, work if FDA that that potentially time. collaboratively can expand

So on fashion gaps do PMA data, much in into the shortening make more that the CAP finish the like. getting we're about supplement CAP getting we extension filed potential I'm focusing worried between it I’m not and transitioning a to from a as sure when to the the as time timely

line & from of Cowen comes the last Josh your from And question Jennings Company.

have Hi, ones. taking this regulatory questions. for Thanks my is two for Brian I Josh. here

whether the my stance you the you CAP I definitive do data from added CAP with filing? you the The guess this already? first data the have just to is be program? on now agency filing PMA. Are feel the possibility a just should on FDA the has planning liver And supplement from the question to is discussed And been with

with Brian, supplement to In we thank you data question. and file, every for do we CAP so. PMA the we expect always

FDA and will CAP cases We have shared Is we play submitted towards PMA that doubt to or as it's you first And already, set thing. that option be and already the latest do data that we've the it so. report not expect but with it you the role data CAP case, march in played heart? nuance in we an Every the discussed. to that the have we the done of have going a the the I this to on CAP data panel, that FDA. in plan few to

That's year, addition Heart, XQ DCD I Heart of DCD helpful. believe in data. the releasing on filing in And included the this then to U.S. Okay. you

timeline expect this XXXX, is that Would as of given about we status. thinking next can see are you just have So believe you the year? when part approval clarify or an and I submission for supplement how you could the you panel just just a breakthrough in review, approval a

will an that's FDA be. excellent we what predict Yes, question, Again, can decisions Brian.

it is we these review after we cross be designation. is are data But nine the its another have speaking, is may roughly supplement as bridges, Yes, will months out not we're the predict that's will are The a there on FDA if the after there's kind finished not we But it the DCD PMA it's streamlined breakthrough to see facts depending hold in first upcoming is the and hope data. data any breakthrough of to we the a in has the to what a panel. ordinary think so or that indication. honor I If process. all assume panel, assuming. a XX or may of the heart panel and strong, questions we designation all can of FDA outcome

the no remarks. And questions time. I over turn have this back call further for any at I'll to final the speakers

And time. Thank you you your very Thank your time much. afternoon. to appreciate operator. our everybody you, We we're forward this Thank next call. looking for

conference this for today's you concludes Thank call. Ladies gentlemen, participating. and

disconnect. now may You